Status:
COMPLETED
RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Child Development Disorders, Pervasive
Eligibility:
All Genders
4-13 years
Phase:
NA
Brief Summary
This 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training progra...
Detailed Description
PDD can be a profoundly disabling condition across social, emotional, and academic domains. Safe and effective treatments for PDD are needed. Participants are randomly assigned to receive either risp...
Eligibility Criteria
Inclusion
- Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder not otherwise specified
- Weight \> 30 lbs
- IQ \>= 35 or mental age of at least 18 months
Exclusion
- Psychotic Disorder
- History of intolerance or nonresponse to risperidone
- Pregnancy
- History of neuroleptic malignant syndrome
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00080145
Start Date
February 1 2004
End Date
September 1 2007
Last Update
August 16 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06520
2
Indiana University
Indianapolis, Indiana, United States, 46202
3
Ohio State University
Columbus, Ohio, United States, 43210